Specificity of two HIV screening tests detecting simultaneously HIV-1 p24 antigen and antibodies to HIV-1 and -2.

Abstract:

:This study aimed at assessing the specificity of the Elecsys® HIV combi PT in comparison to the ARCHITECT® HIV Ag/Ab Combo. With both of these assays, 3997 unselected sera from patients of a tertiary health care centre in Basel, Switzerland, were screened for HIV. Reactive sera were reanalysed on the VIDAS® HIV Duo Ultra to identify false-reactive specimens prior to confirmation by quantitative PCR and line immunoassay. The Elecsys® compared to the ARCHITECT® shows a similar specificity (99.7% versus 99.8%) but a slightly lower positive predictive value (71.8% versus 80%). Samples tested with a cut-off index (COI) between 0.91 and 4.85 (cut-off <0.9) with the Elecsys® and with a signal to cut-off index (S/CO) between 1.09 and 12.49 (cut-off <1.0) with the ARCHITECT® were false-reactive. There was no false-reactive result with the VIDAS®. Of the false-reactive samples, 66.7% could be related to patient-specific underlying conditions. The HIV two-tiered diagnostic algorithm proposed in this work improved the positive predictive values of the Elecsys® or ARCHITECT® to 100% when the results of the VIDAS® were included. Values just above the cut-off are highly suspicious to be false-reactive and high COI or S/CO ratios are associated with true positivity.

journal_name

J Virol Methods

authors

Blaich A,Buser A,Stöckle M,Gehringer C,Hirsch HH,Battegay M,Klimkait T,Frei R

doi

10.1016/j.jviromet.2017.09.005

subject

Has Abstract

pub_date

2017-11-01 00:00:00

pages

143-146

eissn

0166-0934

issn

1879-0984

pii

S0166-0934(17)30420-2

journal_volume

249

pub_type

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